Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study

Overview

Sacubitril/valsartan is an angiotensin receptor neprilysin inhibitor with the ability to reduce myocardial hypertrophy, cardiac remodeling and cardiorenal fibrosis. The compound is also believed to have antiarrhythmic properties as it has been shown to significantly reduce ventricular arrhythmias in patients with implantable cardioverter defibrillators.

Patients suffering from heart failure with reduced ejection fraction show impaired heart rate variability, knowing that in these patients such impairment is highly associated with an increased risk of sudden cardiac death.

In its pivotal study, sacubitril/valsartan demonstrated a significant advantage over enalapril in terms of cardiovascular mortality and rehospitalization.

Against this background, this study was designed to analyze the largely unknown electrophysiological effects of sacubitril/valsartan on the autonomic cardiac nervous system by determining heart rate variability.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2022

Interventions

  • Drug: sacubitril/ valsartan
    • Heart rate variability measurement is carried out by means of a 12-channel ECG for 30 minutes in supine position followed by 10 minutes in standing position. All parameters, including blood values and echocardiographic parameters are assessed before beginning of sacubitril/ valsartan therapy and 3 months after starting treatment

Clinical Trial Outcome Measures

Primary Measures

  • Changes in heart rate variability
    • Time Frame: 24 months
    • Changes in heart rate variability after 3 months of treatment with sacubitril/ valsartan
  • Changes in left ventricular ejection fraction (%)
    • Time Frame: 24 months
    • Changes in left ventricular ejection fraction (%) assessed by transthoracic echocardiogramChanges in echocardiographic parameters (left ventricular parameters)
  • Changes in mitral insufficiency grade
    • Time Frame: 24 months
    • Changes in mitral insufficiency grade assessed by transthoracic echocardiogram
  • Changes in serum NT-proB-Type natriuretic peptide (ng/l)
    • Time Frame: 24 months
    • Changes in laboratory parameters (serum NT-proB-Type natriuretic peptide (ng/l)
  • Changes in Serum creatinine level (mg/dl)
    • Time Frame: 24 months
    • Changes in laboratory parameters (Serum creatinine level (mg/dl)
  • Changes in glomerular filtration rate (ml/min)
    • Time Frame: 24 months
    • Changes in laboratory parameters (glomerular filtration rate ml/min)
  • Changes in serum potassium level (mmol/l)
    • Time Frame: 24 months
    • Changes in laboratory parameters (glomerular filtration rate ml/min)

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with symptomatic severe heart failure with reduced ejection fraction (LVEF ≤40%,)
  • Age > 20 years
  • Consent capacity
  • Sinus rhythm
  • Suitable for a drug conversion from AT1/ACE inhibitors to sacubitril/ valsartan

Exclusion Criteria

  • Age < 18 years
  • Atrial fibrillation
  • Pregnancy
  • Lack of consent capacity
  • Contraindications for a therapy with sacubitril/ valsartan

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Josefs-Hospital Wiesbaden GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Joachim Ehrlich, MD, +496111771201, jehrlich@joho.de

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